Pluristem Carving Out Distinct Niche in Orthopedic Medicine With New Clinical Trials in Rotator Cuff Repair

Pluristem (NASDAQ: PSTI) recently announced a new Phase I trial to check safety and evaluate effectiveness of its PLX-PAD cells in chronic tendonitis often leading to rotator cuff disorders, common in tennis players and golfers, where there are roughly 200,000 rotator cuff surgeries done each year in the US alone. Major insurers put the overall cost of rotator cuff operations at $6,700 each, with a lucrative $1,700 in doctor fees, draining our health care system of over $1.3 billion. Although cell therapy is not commonly associated with sports medicine procedures, it's time something new is tried to take down costs of these pricey procedures, something that doesn't involve dangerous devices or daily pill-popping.

Stem cell treatments are usually associated with serious diseases like cancer and chronic heart conditions, but have recently taken on the glamour of a potential quick-fix in the world of sports, causing celebrity athletes like Jason Kidd of the NY Knicks or NBA All-Star Allan Houston to seek them out in hopes of fast recoveries and better performance. Ethical considerations were bypassed when it became possible to use adult stem cells from fat, bone marrow or, even better, the birth placenta, rather than the embryo of an unborn child. The Catholics breathed easier.

In the past, academic institutions produced only spotty research for using cell therapy in sports and there have been no meaningful clinical trials targeting the human stem cell to treat sports medicine injuries. Dr. Jason Dragoo, top orthopedic surgery professor at the Stanford School of Medicine, spoke out last year to Sports Illustrated about the false hopes given to athletes by stem cell charlatans responding to pressure from owners, coaches and team sponsors.

He didn't have an answer then, but Pluristem may have one now.

Like all of the company's studies, the one for rotator cuff injuries is small and efficient, just 30 patients with only a six-month follow-up. If successful, we imagine third-party payors will be thrilled to recommend Pluristem's procedure over the expensive alternative.

Fixing damaged rotator cuffs with cell therapy is a great addition to Pluristem's growing niche in orthopedic medicine, blending well with ground-breaking clinical trials in hip replacement that we wrote about last August. The global market for artificial hips runs around $5 billion with no end in sight for growth as the world population ages and puts on weight. Companies that make devices for hip repair continue to prosper but the flip side is the heavy litigation of the industry -- watch late-night cable and you can't miss an ad for plaintiffs wanting to sue DePuy, a Johnson & Johnson company, where it was recently reported the number of lawsuits are over 4,000.

As we also observed back in August, Pluristem's platform technology in just that one indication could open up more opportunities within the huge $2.2 billion sports medicine market. In less than a year, that promise looks to become a reality.

A check with our orthopedic physician contacts revealed that hopes for stem cell therapy in sports medicine was originally pinned on repairing and restoring injured cartilage, particularly because such a treatment would have far-reaching medical promise for arthritis. Then came monoclonal antibodies, like the now widely-used Humira by Abbott Laboratories, and for a time stem cells in orthopedics was forgotten. Pluristem's new trials in shoulders, along with hips, target two major joints in the human anatomy that take on a lot of strain in active individuals, and should grab much attention as results from the studies are publicized.

All told, a great call for Pluristem. Medically, they are going after high-cost, high growth markets where orthopedic doctors are considered the tinkerers of hands-on surgeons. These practitioners love to experiment and their own hospital departments are usually second only to cardiology in pulling in big numbers. From a global marketing standpoint, the choice of branching out into sports medicine is brilliant. Pluristem has demographics in their favor and with healthcare economics in a never-ending downward spiral, a new and less invasive treatment with PLX-PAD cells offering reduced post-operative downtime will be the way healthcare insurers (and patients) want to go.

The complete version of this report by Ray Dirks of Ray Dirks Research can be found at: http://www.biomedreports.com/20130508135046/pluristem-carving-out-distinct-niche-in-orthopedic-medicine-with-new-clinical-trials-in-rotator-cuff-repair.html

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